Many microbial infections arise endogenously. Bacteria and yeast are a part of the normal flora of the skin. They also exist prevalently on all mucous membrane surfaces as indigenous flora. Given the proper circumstances and opportunity to penetrate tissues, bacteria from the indigenous flora can set up infections, such as gas gangrene, vulvovaginal abscess, chronic sinusitis, and Vincent's disease.
While good oral hygiene, as achieved by brushing the teeth with a cleansing dentifrice, may help reduce the incidence of periodontal disease, it does not necessarily prevent or eliminate its occurrence. This is because microorganisms contribute to both the initiation and progress of periodontal disease. Thus, in order to prevent or treat periodontal disease, these micoorganisms must be suppressed by some means other than simple mechanical scrubbing. Towards this end, there has been a great deal of research aimed at developing therapeutic dentifrices, mouthwashes, and methods of treating periodontal disease which are effective in suppressing these microorganisms. Treatment with monoperoxy acid compounds has been suggested in treating microbial infections of the oral cavity.
Monoperoxy acids are known for treating microbial diseases of the oral cavity. U.S. Pat. No. 4,990,329, issued Feb. 5, 1991 to Sampathkumar discloses an oral hygiene composition comprising a monoperphthalic acid compound or its pharmaceutically-acceptable salts or esters. These compositions are used to treat or prevent anaerobic infections in humans and lower animals.
U.S. Pat. No. 4,886,658, issued Dec. 12, 1989 to Charbonneau discloses methods for treating or preventing dental plaque, caries, or gingival or periodontal diseases of the oral cavity in humans or lower animals, with reduced staining of teeth or dentures. Compositions suitable for use in this invention comprise a monoperoxyphthalate compound and an anti-plaque bisbiguanide compound.
U.S. Pat. No. 4,716,035, issued Dec. 29, 1987 to Sampathkumar discloses oral compositions comprising certain organic peroxy acid agents and a source of fluoride ions. These compositions are used as anticaries and antigingivitis agents.
Monoperoxy acids are also used for other disinfecting/cleansing purposes. European Patent Application No 0,133,354 published Feb. 20, 1985 by Interox Chemicals Limited, discloses denture cleansing compositions comprising an organic peroxygen compound, especially in effervescent tablet form.
Great Britain Patent Specification No. 2,137,822A, published Oct. 17, 1984 by Interox Chemicals Limited, discloses an alkanolic solution of a magnesium salt of an aryl, cycloaliphatic, or conjugated aliphatic carboxylic acid (substituted by one or more peroxycarboxylic acid groups). This invention is said to be useful as a broad spectrum disinfectant/sterilizing agent for hard surfaces.
U.S. Pat. No. 4,917,815, issued Apr. 17, 1990 to Beilfuss et al., discloses aqueous solutions of aromatic percarboxylic acids. Uses for this invention include acidic or neutral liquid disinfectants for surfaces with low to medium loading of dirt for the skin, the mucous membranes or the hands.
U.S. Pat. No. 4,490,269 issued Dec. 25, 1984 to Gallopo discloses a denture cleansing composition comprising an effervescent agent, and as a bleaching agent, a monoperphthalate or a potassium monopersulfate and a monoperphthalate.
U.S. Pat. No. 4,221,660, issued Sept. 9, 1980 to Eggensperger et al., discloses a method for disinfecting an aqueous system with a solid aromatic percarboxylic acid having solubility in water. Percarboxylic acids which may be employed in this invention includes monoperphthalic acid.
When a granule oral composition comprising a monoperphthalic acid compound and a suitable carrier material(s) is desired, it is necessary to obtain a homogeneous mix of the monoperphthalic acid compound with the suitable carrier materials. These granule oral compositions of the present invention may be used alone or dissolved in an aqueous medium (e.g. water) and utilized as a mouthrinse or mouth spray for treating or preventing microbial infections in the oral cavity of humans and/or lower animals in need of such treatment. When said granule oral compositions are dissloved in an aqueous medium, a rapid and complete dissolution of the granule monoperphthalic acid compound-containing compositions is necessary to ensure clarity and efficacy of these products.
In spite of the prior disclosures, there remains a need for granule oral compositions comprising a monoperphthalic acid compound and a suitable carrier material(s) which provide a homogeneous mixture and rapid dissolution of these components. Surprisingly, it has been discovered that when the particle sizes of the components of possible suitable carrier materials, are maintained at ranges from about 40 microns to about 500 microns, a homogeneous granule composition is achieved which exhibits rapid dissolution in an aqueous medium.
It is an object of the present invention to provide granule oral compositions for treating and/or preventing microbial infections in the oral cavity of humans and/or lower animals in need of such treatment comprising a monoperphthalic acid compound and a suitable carrier material(s), wherein the particle sizes of the suitable carrier materials(s) are from about 40 microns to about 500 microns.
It is also an object of the present invention to provide a granule oral composition comprising a monoperphthalic acid compound and a suitable carrier material(s) that exhibits a homogeneous mix of ingredients and a rapid dissolution time (from about 15 seconds to about 50 seconds). An additional object of the present invention is to provide methods for treating or preventing microbial infections of the oral cavity by administering to humans or lower animals in need of such treatment an oral composition comprising a monoperphthalic acid compound and a suitable carrier material(s) wherein the particle sizes of the suitable carrier material(s) are from about 40 microns to about 500 microns.
These and other objects of the present invention will be apparent from the detailed description of the invention contained hereinafter.
All percentages and ratios herein are by weight and all measurements are made at 25.degree. C. unless otherwise specified.